Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Depression Anxiety and Stress Scale 21
研究概览
简要总结
Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction and psychological distress. Subgingival Instrumentation will be done for treating periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any change in masticatory dysfunction and psychological distress by improved periodontal health.
详细描述
Literature reveals that there occurs masticatory dysfunction in patients with Stage III and IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis and aesthetics of the patient can have an effect on the psychological distress in a chronic state.
Patients of Stage III and Stage IV Periodontitis with the following criteria will be included :
- Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Exclusion Criteria: Patients with
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- History of periodontal treatment within the 6 months
- Patients wearing orthodontic appliances
- Diagnosed psychiatric disorder
- History of antibiotic use within the previous 3 months
- History of use of Steroid, immunosuppressive and psychiatric drugs
- Pregnant and lactating women
- Smoking or substance abuse
- History of Menopause
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
- •Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
排除标准
- •Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- •Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- •Periodontal treatment within the 6 months
- •Patients wearing orthodontic appliances
- •Any diagnosed psychiatric disorder
- •Antibiotic use within the previous 3 months
- •Steroid, immunosuppressive and psychiatric drug use
- •Pregnant and lactating women
- •History of menopause
- •Smoking or substance abuse
结局指标
主要结局
Depression Anxiety and Stress Scale 21
时间窗: Baseline, 2 months, 3 months
DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
Masticatory performance
时间窗: Baseline, 2 months, 3 months
Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
Hospital Anxiety and Depression Scale 14
时间窗: Baseline, 2 months, 3 months
The HADS constitutes 14 items grouped into two subscales: "anxiety subscale" (HADS-A), as well as "depression subscale" (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
次要结局
- Pocket Probing Depth(Baseline, 2 months, 3 months)
- Clinical attachment level(Baseline, 2 months, 3 months)